SOFT-55 EW APHAKIC (VIFILCON A) SOFT(HYDROPHILIC) SPHERICAL CONTACT LENS FOR EXTENDED WEAR
FDA premarket approval P960039/S002 · decided 2002-01-03
Approval details
- PMA number
- P960039
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SOFT-55 EW APHAKIC (VIFILCON A) SOFT(HYDROPHILIC) SPHERICAL CONTACT LENS FOR EXTENDED WEAR
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Unilens Corporation, USA
- Date received
- 2001-01-29
- Decision date
- 2002-01-03
- Days to decision
- 339 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Largo, FL
- Statement
- APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT UNILENS CORPORATION, USA, LARGO, FLORIDA.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.